MedTrace Logo

Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft

NCT05447793 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-07-07

No results posted yet for this study

Summary

Partial thickness skin grafts are widely used to cover large losses of substance secondary to trauma, burns, ulcers, neoplasms.

The donor site (SD), in principle, heals by spontaneous re-epithelialization from the epithelial residues of the skin appendages.

In the post-surgical management of the collection area, in order to optimize treatment, the following are necessary: control of nappy bleeding, management of transudate, avoid superinfection, promote rapid re-epithelialization and pain control.

The objective of the research proposed by us wants to compare two methods of dressing of the SD, one of which involves the use of impregnated gauze and cream with Rigenase and poliesanide (Fitostimoline Plus®) while the other the use of impregnated gauze and cream with hyaluronic acid, sodium salt and 1% silver sulfadiazine (Connettivina Bio Plus®) associated with non-adhesive polyurethane foam (i.e. without adhesive edge, i.e. Mepilex).

The prospective, multicentre study will be conducted at the UOC of Plastic and Reconstructive Surgery of our AOU directed by Prof F. D'Andrea and the UOC of Plastic and Reconstructive Surgery of ASUGI of Trieste directed by Prof Z. Arnez.

To date, there is still no standardized protocol on the wound care of the graft harvesting area. If the literature is evaluated, in fact, large variations in the management of SD are observed with a discrepancy between the practice and the evidence reported in the literature.

The purpose of our research is precisely to review the literature on the effectiveness of dressings at the sampling site level in terms of reducing pain and promoting rapid healing.

Conditions

  • Wounds and Injuries
  • Skin Graft Scar
  • Skin Graft Complications

Interventions

DEVICE

Fitostimoline plus

Formulation in gauzes and cream

DEVICE

Connettivina bio plus

Formulation in gauzes and cream

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-12-18
Completion
2022-09-18

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447793 on ClinicalTrials.gov